FDA Reviews Policies on Off-Label Promotion, Online Advertising

The FDA conducted a public hearing November 9-10 to discuss whether pharmaceutical companies should be allowed to promote drugs for unapproved uses. The FDA also announced that it would fund studies to investigate the responsible promotion of drugs on online platforms.

The 2-day hearing was announced by the FDA in September as a way to gather input as it continues to review its policy prohibiting the promotion of FDA-approved drugs for unapproved, or off-label, uses. It invited pharmaceutical companies to comment on how their promotion of drugs for unapproved uses “can provide access to information that is relevant, scientifically sound [and] responsibly presented,” and asked for “input from stakeholders on how increased communications from firms about unapproved uses could impact the public health.” This input, along with public comments, would help the FDA develop standards to minimize the risk of off-label promotions to be misleading or to cause harm, the announcement stated.

The reevaluation of the policy was sparked by court decisions in favor of drug companies in 3 separate cases that alleged the FDA had violated the companies’ First Amendment right to free speech by prohibiting them from disseminating information on off-label use. Most recently, a district court ruled in March 2016 that Amarin’s promotional statements discussing an unapproved use of its drug were “truthful and non-misleading,” prompting the FDA to settle.

At the hearing, pharmaceutical companies making the case for off-label promotions were met with skepticism and caution from FDA representatives and patient safety advocates. FDA Commissioner Robert Califf, MD, opened the hearing by acknowledging that truthful information on off-label use could potentially help providers discover better treatments for their patients, while also reiterating the FDA’s concern that some communications could use unsound science to mislead audiences about a product’s benefits and risks. Pharmaceutical representatives argued that healthcare professionals should be allowed access to the most complete information about treatment options, but the FDA questioned whether drug companies could be the most accurate and transparent source of this information.

One day before the start of the off-label hearing, the FDA also indicated that it may clarify its policies regarding online drug promotion. According to a Federal Register notice, it will research whether prescription drug risk information can be sufficiently conveyed in online communications limited by character space. The proposed studies aim to determine whether including a link to risk information is as effective as including substantive risk information in the message. The issue of linking to save space is especially relevant when using Twitter, which limits each tweet to 140 characters.

The use of character-limited communications for drug promotion is currently fraught with uncertainty, as it is only discussed by the FDA in a set of recommendations, not requirements. These draft guidelines from 2014 suggest that each message should state the drug’s benefit and risk information and include a link that directs the reader to a website detailing the drug’s risks, if possible. Due to the lack of clear direction, pharmaceutical companies are hesitant to promote drugs in tweets due to their worry of violating FDA rules, according to STAT. The drug companies are hopeful that the new studies will suggest that links are an acceptable method of communicating risks, which could prompt the FDA to issue a concrete policy regarding online drug promotion.